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FDA Date: 7/7/10
Qualaquin (quinine sulfate) FDA Drug Safety Communication
New Risk Management Plan and Patient Medication Guide for Qualaquin (quinine sulfate)
Due to continued reports of serious side effects in patients using Qualaquin "off-label" (non-FDA-approved use) for nighttime leg cramps, the FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for nighttime leg cramps. Qualaquin is ONLY FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, a rare infection in the United States, primarily in travelers returning from malaria-endemic areas.
The risk management plan, called a Risk Evaluation and Mitigation Strategy (REMS), requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider (DHCP) Letter warning of the risk of serious and life-threatening hematologic (blood-related) reactions.